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NCT07621614From ClinicalTrials.govRecruiting

A Study on How to Safely Guide Surgery for Melanoma and Similar Skin Tumors in Children Using Pathology and Genetic Information

A Multi-Institutional Central Pathology and Molecular Risk-Based Stratification Study of Surgical Management for Melanoma, Atypical Spitz/Spitzoid Tumors, and Other Atypical Melanocytic Neoplasms in Pediatric Patients

  • Clinical Stage 0 Cutaneous Melanoma AJCC v8
  • Clinical Stage I Cutaneous Melanoma AJCC v8
  • Clinical Stage II Cutaneous Melanoma AJCC v8
  • Cutaneous Melanocytic Neoplasm
  • Cutaneous Melanoma
  • Cutaneous Spitz Melanocytoma
  • Cutaneous Spitz Melanoma

At a glance

Phase
Phase 2
Study type
Interventional
Sponsor
Children's Oncology Group
Enrolment target
51
Started
15 May 2027
Main results due
31 July 2028
Study sites
13
Registry updated
24 September 2026

Can you take part?

  • Up to 25 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

* Patients ≤ 25 years old
* Newly diagnosed localized cutaneous melanoma, atypical Spitz/Spitzoid tumors, or other atypical melanocytic neoplasm by local institution pathology report
* Patients must have disease that is localized to the skin on clinical assessment. Note that staging imaging is not required for the determination of eligibility, but if obtained prior to enrollment, all imaging must be consistent with localized cutaneous disease
* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients ≤ 16 years of age
* Patients must not have received any prior chemotherapy, immunotherapy, targeted therapy, radiation, or surgical therapy for melanoma other than the permitted biopsy/excision of the lesion for which they are enrolling. Note that prior biopsies/surgery for other benign melanocytic lesions is permitted

Exclusion Criteria:

* Patients ≥ 18 years old with conventional adult-type melanoma are excluded. Note that patients 18-25 years old with atypical Spitz/Spitzoid tumors, or other atypical melanocytic neoplasms are eligible
* Patients with clinical evidence of metastatic disease such as palpable malignant adenopathy or symptomatic distant metastases are not eligible
* Patients who have undergone re-excision to achieve a negative margin or sentinel lymph node biopsy for the melanocytic neoplasm under study are not eligible. Note that this does not exclude patients who have undergone the permitted diagnostic biopsy/excision, including re-biopsy, of the lesion
* Any of the following diagnoses

  * Congenital nevi-associated proliferative nodules
  * Agminated Spitz nevi/tumors
  * Dysplastic nevus
  * Combined nevus
  * CRTC1::TRIM11 and/or MED15::ATF1 fused tumors (molecular testing is not required prior to enrollment)
* Pre-existing conditions:

  * Solid organ transplant recipients
  * Known melanoma predisposition syndrome (i.e., patients with previously known pathogenic variants in moderate and high penetrance melanoma susceptibility genes \[i.e., CDKN2A, CDK4, BAP1, POT1, TERT promoter, ACD, TERF2IP\] or Xeroderma Pigmentosum). Note germline testing is not required prior to enrollment
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

What this study is about

In the sponsor’s own words, from the registry.

This phase II trial compares the effect of using risk-based stratification to guide surgical management to the usual approach in treating cutaneous melanoma, atypical Spitz/Spitzoid tumors or other atypical melanocytic tumors that have not spread to other parts of the body (localized). Melanoma is a cancer that in children is sometimes difficult to tell apart from benign (not harmful) or atypical (uncertain if harmful) skin lesions. Failure to diagnose melanoma can result in inadequate surgical removal and increase the risk of recurrence and metastatic disease (spread from where it first started to other places in the body). In addition, diagnosing a tumor a benign (not cancer) tumor as cancer may lead to unnecessary surgery and treatment. This trial reviews tumor pathology and genetic markers and classifies the tumor as not atypical, atypical but low risk for spread and/or recurrence (coming back after a period of improvement), and atypical and high risk for spread and/or recurrence. The classifications are then used to provide surgical recommendations. Tumors that are not atypical do not receive any surgical treatment. Low-risk recommendations include removing a small layer of normal skin around the tumor. High-risk recommendations include the usual adult melanoma approach of removing a larger layer of normal skin around the tumor with or without a biopsy of the sentinel lymph node (the first lymph node to which tumor cells are likely to spread from a primary tumor). Risk-based guided surgical management may help avoid unnecessary surgery while improving outcomes in younger patients with localized cutaneous melanoma, atypical Spitz/Spitzoid tumors or other atypical melanocytic tumors.

Study sites(13)

  • Kaiser Permanente-Oakland

    Oakland, California, United States

    Recruiting

  • Alfred I duPont Hospital for Children

    Wilmington, Delaware, United States

    Recruiting

  • Nemours Children's Clinic-Jacksonville

    Jacksonville, Florida, United States

    Recruiting

  • Nemours Children's Hospital

    Orlando, Florida, United States

    Recruiting

  • Nemours Children's Clinic - Pensacola

    Pensacola, Florida, United States

    Recruiting

  • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

    Toledo, Ohio, United States

    Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, United States

    Recruiting

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, United States

    Recruiting

  • East Tennessee Childrens Hospital

    Knoxville, Tennessee, United States

    Recruiting

  • Saint Jude Children's Research Hospital

    Memphis, Tennessee, United States

    Recruiting

  • Dell Children's Medical Center of Central Texas

    Austin, Texas, United States

    Recruiting

  • UT MD Anderson Cancer Center

    Houston, Texas, United States

    Recruiting

  • Primary Children's Hospital

    Salt Lake City, Utah, United States

    Recruiting

Showing 13 of 13 sites. 13 of the 13 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07621614. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study on How to Safely Guide Surgery for Melanoma and Similar Skin Tumors in Children Using Pathology and Ge | Trialion